Can Apretude (cabotegravir) be taken during pregnancy?

Apretude (Cabotegravir) Use During Pregnancy

Apretude (cabotegravir) should not be used during pregnancy due to insufficient human data on safety and potential risks to the fetus. 1

Safety Classification and Evidence

• Cabotegravir has insufficient human data to adequately assess drug-associated risks of birth defects and miscarriage during pregnancy 1
• The FDA label for Apretude (cabotegravir) indicates that a pregnancy exposure registry has been established to monitor pregnancy outcomes in individuals exposed to cabotegravir during pregnancy 1
• In animal reproduction studies with oral cabotegravir, concerning effects were observed including:
  • Delay in the onset of parturition at high doses 1
  • Increased stillbirths and neonatal deaths at exposures >28 times the recommended human dose 1

Risks and Considerations

• Studies in pregnant rats showed that cabotegravir crosses the placenta and can be detected in fetal tissue 1
• Cabotegravir is present in animal milk, suggesting it would likely be present in human milk as well 1
• The background risk for major birth defects in the general population is 2.7%, and the estimated background rate of miscarriage is 15-20% 1
• Many pregnant women have heightened concerns about medication use during pregnancy, often avoiding medications when possible due to perceived risks 2

Recommendations for HIV Prevention During Pregnancy

• For HIV prevention during pregnancy, alternative PrEP options with better established safety profiles should be considered 1
• The FDA recommends healthcare providers register pregnant patients who have been exposed to cabotegravir with the Antiretroviral Pregnancy Registry 1
• When considering any medication during pregnancy, the potential benefits must be weighed against the potential risks to both the mother and fetus 3

Clinical Decision-Making

• If a woman becomes pregnant while using Apretude, she should discuss with her healthcare provider about transitioning to an alternative HIV prevention method with more established safety data 1
• For women at high risk of HIV acquisition during pregnancy, oral PrEP options may be more appropriate based on available safety data 4
• The decision to use any antiretroviral drug during pregnancy should be made after thorough discussion between the healthcare provider and the patient regarding benefits versus risks 5

Monitoring and Follow-up

• If exposure to cabotegravir occurs during pregnancy, healthcare providers should register the patient with the Antiretroviral Pregnancy Registry at 1-800-258-4263 1
• Long-term follow-up is recommended for all infants born to women who have received antiretroviral drugs during pregnancy 5
• Monitoring for potential adverse effects in both mother and infant is essential if exposure occurs 1

Apretude represents a novel long-acting injectable option for HIV prevention, but its safety profile during pregnancy has not been established. Until more human data becomes available, alternative HIV prevention strategies with better-documented safety profiles should be prioritized during pregnancy.